📋 FDA Reference
Pacemaker Electrode Perm Temp
Daig
Summary: The pacemaker electrode perm temp by Daig is a cardiac device used to regulate heart rhythms. It is primarily used by cardiologists in patients requiring temporary pacing support.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800351 ↗
Decision Date ?
May 28, 1980
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on May 28, 1980. Manufactured by Daig, it is classified as a Class 3 device under product code DTB.
What It Is
The pacemaker electrode perm temp is a cardiac device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in temporary pacing situations, where short-term support is needed to stabilize a patient's cardiac rhythm. The device consists of an electrode that is placed in contact with the heart muscle, delivering controlled electrical stimuli.
FDA-Cleared Indications
- Temporary cardiac pacing for patients who require short-term electrical support of the heart rate.
- Temporary pacing during acute bradycardia or heart block when the rhythm disturbance is expected to resolve or stabilize.
- Temporary pacing in perioperative or intensive-care settings when clinical monitoring and pacing support are required.
Clinical Applications
- Temporary pacing support for acute symptomatic bradycardia.
- Temporary pacing for heart block or other acute conduction disturbances.
- Perioperative cardiac pacing when short-term rhythm support is needed.
- Temporary pacing in an intensive-care or emergency setting with continuous cardiac monitoring.
Practical Considerations
- The electrode must be selected for compatibility with the pacing generator and other components of the temporary pacing system.
- Proper placement against the heart is necessary to achieve effective electrical capture and reduce complications.
- Use requires continuous cardiac monitoring and access to equipment for managing arrhythmias and pacing complications.
- The record provided does not establish MRI safety; MRI should be avoided unless the complete implanted or connected system has specific MRI-conditional labeling.
- This device is intended for temporary support, not as a substitute for evaluation of medication, permanent pacemaker implantation, surgery, or treatment of the underlying rhythm disorder.
Related Literature
The linked study titled 'Outcomes of primary leadless pacemaker implantation: A systematic review' from 2023 reviews the use of leadless pacemakers as an alternative to traditional pacemakers. It highlights the growing prevalence of leadless devices but notes a lack of consolidated data on their use in emergency situations. Key findings suggest potential benefits in terms of reduced complications, although more research is needed to fully understand their efficacy and safety in acute settings.
Frequently Asked Questions
What is the pacemaker electrode perm temp used for?
It is used for temporary cardiac pacing in patients with heart rhythm disturbances.
What specialties typically use this device?
Cardiologists and electrophysiologists in hospital settings, especially in emergency and perioperative care.
What are the FDA-cleared indications?
It is indicated for temporary pacing in patients with acute heart rhythm issues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.